Demo logical data model
1.0.0 - STU1
Demo logical data model
1.0.0 - STU1
Demo logical data model, published by My Organization. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/wgroup6/11615 and changes regularly. See the Directory of published versions
| Official URL: http://example.com/fhir/example/StructureDefinition/MedicinalProduct | Version: 1.0.0 | |||
| Active as of 2023-10-31 | Computable Name: IDMP11615Authorised | |||
ISO 11615 Authorised Medicinal Product
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Base
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  MedicinalProduct | 0..* | Base | Instances of this logical model are not marked to be the target of a Reference | |
  MPID | 1..1 | II | This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2) | |
| CombinedPharmaceuticalDoseForm | 0..1 | CD | The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3) | |
| AdditionalMonitoringIndicator | 0..1 | CD | If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4) | |
| SpecialMeasures | 0..* | ST | If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5) | |
| PaediatricUseIndicator | 0..1 | CD | This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6) | |
| OrphanDesignationStatus | 0..1 | CD | The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7) | |
 AttachedDocument | 1..* | Class | 9.2.2.11 | |
 Identifier | 1..1 | II | The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2) | |
| EffectiveDate | 1..1 | DT | The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3) | |
| Type | 1..1 | CD | The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4) | |
| Content | 1..1 | ED | The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5) | |
| Language | 0..1 | CD | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6) | |
| MediaType | 0..1 | CD | This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7) | |
| VersionNumber | 0..1 | ST | This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8) | |
 VersionSetIdentifier | 0..1 | II | This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9) | |
| Contraindication | 0..* | Class | 9.9.2.3 | |
| ContraindicationsText | 1..1 | ST | The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2) | |
| ContraindicationsAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4) | |
| Comorbidity | 0..* | CD | The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
 TherapeuticIndication | 0..* | Class | 9.9.2.2 | |
 IndicationText | 1..1 | ST | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) | |
| IndicationAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) | |
| Comorbidity | 0..* | CD | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) | |
| IntendedEffect | 0..1 | CD | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) | |
| Timing-Duration | 0..1 | PQ | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 1..* | Class | 9.9.2.5 | |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| Header | 1..1 | Class | 9.2.2.10 | |
| Identifier | 1..1 | II | This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2) | |
| EffectiveDate | 1..1 | DT | The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3) | |
| Language | 0..1 | CD | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4) | |
| VersionNumber | 0..1 | ST | This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5) | |
| VersionSetIdentifier | 0..1 | II | This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6) | |
| Interactions | 0..* | Class | 9.9.2.7 | |
| InteractionsText | 1..1 | ST | The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2) | |
| Interactant | 0..* | CD | This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3) | |
| InteractionsType | 0..1 | CD | The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4) | |
| InteractionsEffect | 0..1 | CD | The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5) | |
| InteractionsIncidence | 0..1 | CD | The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6) | |
| ManagementActions | 0..1 | CD | The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7) | |
| Manufacturer-Establishment_Organisation | 1..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MarketingAuthorisation | 1..1 | Class | 9.3.2.2 | |
| MarketingAuthorisationNumber | 1..1 | II | The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2) | |
| Country | 1..* | CD | The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3) | |
| LegalStatusOfSupply | 1..1 | CD | The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4) | |
| AuthorisationStatus | 1..1 | CD | The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5) | |
| AuthorisationStatusDate | 1..1 | DT | The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6) | |
| ValidityPeriodStart | 1..1 | DT | The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7) | |
| ValidityPeriodEnd | 1..1 | DT | The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8) | |
| DataExclusivityStartDate | 0..1 | DT | The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9) | |
| DataExclusivityEndDate | 0..1 | DT | The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10) | |
| DateOfFirstAuthorisation | 0..1 | DT | The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11) | |
| InternationalBirthDate | 1..1 | DT | This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12) | |
| JurisdictionalMarketingAuthorisation | 0..* | Class | 9.3.2.10 | |
| Country | 1..1 | CD | This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2) | |
| Jurisdiction | 0..1 | CD | This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3) | |
| MarketingAuthorisationNumber | 0..1 | II | The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4) | |
| LegalStatusOfSupply | 0..1 | CD | The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5) | |
| MarketingAuthorisationHolder_Organisation | 1..1 | Class | 9.3.2.3 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SME | 0..1 | Class | 9.3.2.4 | |
| SMEFlag | 1..1 | BL | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) | |
| Size | 0..1 | CD | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) | |
| SMENumber | 0..1 | II | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) | |
| StatusDate | 0..1 | DT | This is the date when the SME status was granted. (9.3.2.4.4) | |
| MarketingAuthorisationProcedure | 1..1 | Class | 9.3.2.6 | |
| ProcedureIdentifier-Number | 0..1 | II | The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2) | |
| ProcedureType | 1..1 | CD | The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3) | |
| ProcedureDateStart | 0..1 | DT | The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4) | |
| ProcedureDateEnd | 0..1 | DT | The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5) | |
| MarketingAuthorisationApplication | 0..* | Class | 9.3.2.7 | |
| ApplicationIdentifier-Number | 1..1 | II | A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2) | |
| ApplicationType | 1..1 | CD | The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3) | |
| ApplicationDate | 1..1 | DT | The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4) | |
| MedicinesRegulatoryAgency_Organisation | 1..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MarketingStatus | 0..* | Class | 9.3.2.8 | |
| Country | 1..1 | CD | The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2) | |
| Jurisdiction | 0..1 | CD | Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3) | |
| MarketingStatus | 1..1 | CD | This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4) | |
| MarketingDateStart | 1..1 | DT | The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5) | |
| MarketingDateStop | 1..1 | DT | The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6) | |
| RiskOfSupplyShortage | 0..1 | BL | Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7) | |
| RiskOfSupplyShortageComment | 0..1 | ST | Any additional comment on supply shortage. (9.3.2.8.8) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MasterFile | 0..* | Class | 9.2.2.5 | |
| FileType | 1..1 | CD | This attribute is to define which kind of master file is indicated (9.2.2.5.2) | |
| FileCode | 1..1 | II | This attribute is for a code to uniquely identify a master file. (9.2.2.5.3) | |
| MasterFileHolder_Organisation | 0..1 | Class | 9.2.2.6 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MedicinalProductName | 1..* | Class | 9.2.2.8 | |
| FullName | 1..1 | ST | The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2) | |
| InventedNamePart | 0..* | ST | The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3) | |
| ScientificNamePart | 0..* | ST | The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4) | |
| StrengthPart | 0..* | ST | The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5) | |
| PharmaceuticalDoseFormPart | 0..* | ST | The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6) | |
| FormulationPart | 0..* | ST | The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7) | |
| IntendedUsePart | 0..* | ST | The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8) | |
| TargetPopulationPart | 0..* | ST | The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9) | |
| ContainerOrPackPart | 0..* | ST | The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10) | |
| DevicePart | 0..* | ST | The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11) | |
| TrademarkOrCompanyNamePart | 0..* | ST | The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12) | |
| Time-PeriodPart | 0..* | ST | The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13) | |
| FlavourPart | 0..* | ST | The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14) | |
| DelimiterPart | 0..* | ST | A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15) | |
| Country-Language | 1..* | Class | 9.2.2.9 | |
| Country | 1..1 | CD | The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2) | |
| Jurisdiction | 0..1 | CD | The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3) | |
| Language | 1..1 | CD | The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4) | |
| OrphanDesignation | 0..* | Class | 9.2.2.3 | |
| OrphanIndicationType | 1..1 | CD | This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2) | |
| OrphanProcedureNumber | 0..1 | II | This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3) | |
| OrphanDesignationAuthorisationStatus | 1..1 | CD | This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4) | |
| OrphanDesignationAuthorisationDate | 0..1 | DT | This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5) | |
| OrphanDesignationNumber | 0..1 | II | This field is to indicate the orphan designation decision number. (9.2.2.3.6) | |
| PackagedMedicinalProduct | 1..* | Class | 9.6.2.2 | |
| PCID | 1..1 | II | This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1) | |
| PackageDescription | 1..1 | ST | A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2) | |
| BatchIdentifier | 0..* | Class | 9.6.2.8 | |
| BAID1 | 1..1 | II | The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1) | |
| BAID2 | 0..1 | II | The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2) | |
| ExpirationDate | 1..1 | DT | This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MarketingAuthorisation | 0..1 | Class | 9.3.2.2 | |
| MarketingAuthorisationNumber | 1..1 | II | The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2) | |
| Country | 1..* | CD | The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3) | |
| LegalStatusOfSupply | 1..1 | CD | The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4) | |
| AuthorisationStatus | 1..1 | CD | The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5) | |
| AuthorisationStatusDate | 1..1 | DT | The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6) | |
| ValidityPeriodStart | 1..1 | DT | The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7) | |
| ValidityPeriodEnd | 1..1 | DT | The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8) | |
| DataExclusivityStartDate | 0..1 | DT | The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9) | |
| DataExclusivityEndDate | 0..1 | DT | The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10) | |
| DateOfFirstAuthorisation | 0..1 | DT | The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11) | |
| InternationalBirthDate | 1..1 | DT | This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12) | |
| JurisdictionalMarketingAuthorisation | 0..* | Class | 9.3.2.10 | |
| Country | 1..1 | CD | This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2) | |
| Jurisdiction | 0..1 | CD | This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3) | |
| MarketingAuthorisationNumber | 0..1 | II | The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4) | |
| LegalStatusOfSupply | 0..1 | CD | The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5) | |
| MarketingAuthorisationHolder_Organisation | 1..1 | Class | 9.3.2.3 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SME | 0..1 | Class | 9.3.2.4 | |
| SMEFlag | 1..1 | BL | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) | |
| Size | 0..1 | CD | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) | |
| SMENumber | 0..1 | II | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) | |
| StatusDate | 0..1 | DT | This is the date when the SME status was granted. (9.3.2.4.4) | |
| MarketingAuthorisationProcedure | 1..1 | Class | 9.3.2.6 | |
| ProcedureIdentifier-Number | 0..1 | II | The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2) | |
| ProcedureType | 1..1 | CD | The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3) | |
| ProcedureDateStart | 0..1 | DT | The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4) | |
| ProcedureDateEnd | 0..1 | DT | The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5) | |
| MarketingAuthorisationApplication | 0..* | Class | 9.3.2.7 | |
| ApplicationIdentifier-Number | 1..1 | II | A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2) | |
| ApplicationType | 1..1 | CD | The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3) | |
| ApplicationDate | 1..1 | DT | The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4) | |
| MedicinesRegulatoryAgency_Organisation | 1..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MarketingStatus | 0..* | Class | 9.3.2.8 | |
| Country | 1..1 | CD | The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2) | |
| Jurisdiction | 0..1 | CD | Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3) | |
| MarketingStatus | 1..1 | CD | This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4) | |
| MarketingDateStart | 1..1 | DT | The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5) | |
| MarketingDateStop | 1..1 | DT | The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6) | |
| RiskOfSupplyShortage | 0..1 | BL | Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7) | |
| RiskOfSupplyShortageComment | 0..1 | ST | Any additional comment on supply shortage. (9.3.2.8.8) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| PackageItem_Container | 1..* | Class | 9.6.2.3 | |
| PackageItem_ContainerType | 1..1 | CD | The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2) | |
| PackageItem_ContainerQuantity | 1..1 | PQ | The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3) | |
| Material | 1..* | CD | The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4) | |
| AlternateMaterial | 0..* | CD | The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5) | |
| DataCarrierIdentifier | 0..* | Class | 9.6.2.4 | |
| CodeSystem | 1..1 | CD | The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2) | |
| Value | 1..1 | CD | The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3) | |
| Device | 0..* | Class | 9.6.2.12 | |
| DeviceType | 1..1 | CD | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) | |
| DeviceTradeName | 0..1 | ST | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) | |
| DeviceQuantity | 1..1 | PQ | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) | |
| DeviceListingNumber | 0..1 | ST | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) | |
| DeviceIdentifier | 0..1 | II | A unique device identifier needs to be specified. (9.6.2.12.6) | |
| ModelNumber | 0..1 | ST | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) | |
| SterilityIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) | |
| SterilisationRequirementIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) | |
| DeviceUsage | 0..1 | CD | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) | |
| DeviceBatchIdentifier | 0..* | Class | 9.6.2.15 | |
| BatchNumber | 1..1 | ST | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) | |
| ExpirationDate | 1..1 | DT | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) | |
| DeviceMaterial | 0..* | Class | 9.6.2.13 | |
| Substance | 1..1 | CD | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) | |
| Alternate | 0..1 | BL | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) | |
| DeviceNomenclature | 0..* | Class | 9.6.2.14 | |
| CodeSystem | 1..1 | CD | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) | |
| Value | 1..1 | CD | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| ManufacturedItem | 0..* | Class | 9.6.2.20 | |
| ManufacturedDoseForm | 1..1 | CD | This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2) | |
| UnitOfPresentation | 0..1 | CD | This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3) | |
| ManufacturedItemQuantity | 1..1 | PQ | The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4) | |
| Ingredient | 1..* | Class | 9.7.2.2 | |
| IngredientRole | 1..1 | CD | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SpecifiedSubstance | 0..* | Class | 9.7.2.4 | |
| SpecifiedSubstance | 1..1 | CD | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) | |
| SpecifiedSubstanceGroup | 1..1 | CD | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) | |
| Strength | 0..* | Class | 9.7.2.5 | |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Substance | 0..1 | Class | 9.7.2.3 | |
| Substance | 1..1 | CD | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) | |
| Strength | 1..* | Class | 9.7.2.5 | |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| Package_Component | 0..* | Class | 9.6.2.9 | |
| ComponentType | 1..1 | CD | The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2) | |
| ComponentMaterial | 0..* | CD | The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3) | |
| ComponentAlternateMaterial | 0..* | CD | Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| PharmaceuticalProduct | 1..* | Class | 9.8.2.2 | |
| AdministrableDoseForm | 1..1 | CD | This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2) | |
| UnitOfPresentation | 0..1 | CD | The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3) | |
| Device | 0..* | Class | 9.6.2.12 | |
| DeviceType | 1..1 | CD | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) | |
| DeviceTradeName | 0..1 | ST | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) | |
| DeviceQuantity | 1..1 | PQ | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) | |
| DeviceListingNumber | 0..1 | ST | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) | |
| DeviceIdentifier | 0..1 | II | A unique device identifier needs to be specified. (9.6.2.12.6) | |
| ModelNumber | 0..1 | ST | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) | |
| SterilityIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) | |
| SterilisationRequirementIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) | |
| DeviceUsage | 0..1 | CD | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) | |
| DeviceBatchIdentifier | 0..* | Class | 9.6.2.15 | |
| BatchNumber | 1..1 | ST | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) | |
| ExpirationDate | 1..1 | DT | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) | |
| DeviceMaterial | 0..* | Class | 9.6.2.13 | |
| Substance | 1..1 | CD | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) | |
| Alternate | 0..1 | BL | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) | |
| DeviceNomenclature | 0..* | Class | 9.6.2.14 | |
| CodeSystem | 1..1 | CD | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) | |
| Value | 1..1 | CD | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| Ingredient | 1..* | Class | 9.7.2.2 | |
| IngredientRole | 1..1 | CD | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SpecifiedSubstance | 0..* | Class | 9.7.2.4 | |
| SpecifiedSubstance | 1..1 | CD | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) | |
| SpecifiedSubstanceGroup | 1..1 | CD | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) | |
| Strength | 0..* | Class | 9.7.2.5 | |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Substance | 0..1 | Class | 9.7.2.3 | |
| Substance | 1..1 | CD | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) | |
| Strength | 1..* | Class | 9.7.2.5 | |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| PharmaceuticalProductCharacteristics | 0..* | Class | 9.8.2.4 | |
| CodeSystem | 1..1 | CD | The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2) | |
| Value | 1..1 | CD | The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3) | |
| Status | 0..1 | CD | The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4) | |
| PhPIDSet | 1..* | Class | 9.8.2.6 | |
| PhPIDIdentifierSets | 1..1 | II | This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0) | |
| RouteOfAdministration | 1..* | Class | 9.8.2.3 | |
| RouteOfAdministration | 1..1 | CD | The route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0) | |
| ProductClassification | 0..* | Class | 9.2.2.4 | |
| CodeSystem | 1..1 | CD | The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2) | |
| Value | 1..1 | CD | The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3) | |
| ProductCross-Reference | 0..* | Class | 9.2.2.7 | |
| I_MPIDCross-Reference | 1..1 | II | This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2) | |
| ReferencedProductType | 0..1 | CD | This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3) | |
| TherapeuticIndication | 1..* | Class | 9.9.2.2 | |
| IndicationText | 1..1 | ST | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) | |
| IndicationAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) | |
| Comorbidity | 0..* | CD | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) | |
| IntendedEffect | 0..1 | CD | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) | |
| Timing-Duration | 0..1 | PQ | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 1..* | Class | 9.9.2.5 | |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| MedicinalProduct | 0..* | Base | Instances of this logical model are not marked to be the target of a Reference | |
| MPID | 1..1 | II | This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2) | |
| CombinedPharmaceuticalDoseForm | 0..1 | CD | The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3) | |
| AdditionalMonitoringIndicator | 0..1 | CD | If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4) | |
| SpecialMeasures | 0..* | ST | If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5) | |
| PaediatricUseIndicator | 0..1 | CD | This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6) | |
| OrphanDesignationStatus | 0..1 | CD | The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7) | |
| AttachedDocument | 1..* | Class | 9.2.2.11 | |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2) | |
| EffectiveDate | 1..1 | DT | The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3) | |
| Type | 1..1 | CD | The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4) | |
| Content | 1..1 | ED | The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5) | |
| Language | 0..1 | CD | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6) | |
| MediaType | 0..1 | CD | This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7) | |
| VersionNumber | 0..1 | ST | This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8) | |
| VersionSetIdentifier | 0..1 | II | This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9) | |
| Contraindication | 0..* | Class | 9.9.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ContraindicationsText | 1..1 | ST | The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2) | |
| ContraindicationsAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4) | |
| Comorbidity | 0..* | CD | The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| TherapeuticIndication | 0..* | Class | 9.9.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IndicationText | 1..1 | ST | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) | |
| IndicationAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) | |
| Comorbidity | 0..* | CD | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) | |
| IntendedEffect | 0..1 | CD | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) | |
| Timing-Duration | 0..1 | PQ | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 1..* | Class | 9.9.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| Header | 1..1 | Class | 9.2.2.10 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2) | |
| EffectiveDate | 1..1 | DT | The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3) | |
| Language | 0..1 | CD | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4) | |
| VersionNumber | 0..1 | ST | This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5) | |
| VersionSetIdentifier | 0..1 | II | This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6) | |
| Interactions | 0..* | Class | 9.9.2.7 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| InteractionsText | 1..1 | ST | The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2) | |
| Interactant | 0..* | CD | This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3) | |
| InteractionsType | 0..1 | CD | The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4) | |
| InteractionsEffect | 0..1 | CD | The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5) | |
| InteractionsIncidence | 0..1 | CD | The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6) | |
| ManagementActions | 0..1 | CD | The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7) | |
| Manufacturer-Establishment_Organisation | 1..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MarketingAuthorisation | 1..1 | Class | 9.3.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| MarketingAuthorisationNumber | 1..1 | II | The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2) | |
| Country | 1..* | CD | The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3) | |
| LegalStatusOfSupply | 1..1 | CD | The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4) | |
| AuthorisationStatus | 1..1 | CD | The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5) | |
| AuthorisationStatusDate | 1..1 | DT | The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6) | |
| ValidityPeriodStart | 1..1 | DT | The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7) | |
| ValidityPeriodEnd | 1..1 | DT | The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8) | |
| DataExclusivityStartDate | 0..1 | DT | The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9) | |
| DataExclusivityEndDate | 0..1 | DT | The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10) | |
| DateOfFirstAuthorisation | 0..1 | DT | The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11) | |
| InternationalBirthDate | 1..1 | DT | This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12) | |
| JurisdictionalMarketingAuthorisation | 0..* | Class | 9.3.2.10 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2) | |
| Jurisdiction | 0..1 | CD | This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3) | |
| MarketingAuthorisationNumber | 0..1 | II | The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4) | |
| LegalStatusOfSupply | 0..1 | CD | The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5) | |
| MarketingAuthorisationHolder_Organisation | 1..1 | Class | 9.3.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SME | 0..1 | Class | 9.3.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SMEFlag | 1..1 | BL | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) | |
| Size | 0..1 | CD | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) | |
| SMENumber | 0..1 | II | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) | |
| StatusDate | 0..1 | DT | This is the date when the SME status was granted. (9.3.2.4.4) | |
| MarketingAuthorisationProcedure | 1..1 | Class | 9.3.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ProcedureIdentifier-Number | 0..1 | II | The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2) | |
| ProcedureType | 1..1 | CD | The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3) | |
| ProcedureDateStart | 0..1 | DT | The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4) | |
| ProcedureDateEnd | 0..1 | DT | The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5) | |
| MarketingAuthorisationApplication | 0..* | Class | 9.3.2.7 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ApplicationIdentifier-Number | 1..1 | II | A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2) | |
| ApplicationType | 1..1 | CD | The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3) | |
| ApplicationDate | 1..1 | DT | The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4) | |
| MedicinesRegulatoryAgency_Organisation | 1..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MarketingStatus | 0..* | Class | 9.3.2.8 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2) | |
| Jurisdiction | 0..1 | CD | Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3) | |
| MarketingStatus | 1..1 | CD | This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4) | |
| MarketingDateStart | 1..1 | DT | The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5) | |
| MarketingDateStop | 1..1 | DT | The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6) | |
| RiskOfSupplyShortage | 0..1 | BL | Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7) | |
| RiskOfSupplyShortageComment | 0..1 | ST | Any additional comment on supply shortage. (9.3.2.8.8) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MasterFile | 0..* | Class | 9.2.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| FileType | 1..1 | CD | This attribute is to define which kind of master file is indicated (9.2.2.5.2) | |
| FileCode | 1..1 | II | This attribute is for a code to uniquely identify a master file. (9.2.2.5.3) | |
| MasterFileHolder_Organisation | 0..1 | Class | 9.2.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MedicinalProductName | 1..* | Class | 9.2.2.8 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| FullName | 1..1 | ST | The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2) | |
| InventedNamePart | 0..* | ST | The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3) | |
| ScientificNamePart | 0..* | ST | The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4) | |
| StrengthPart | 0..* | ST | The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5) | |
| PharmaceuticalDoseFormPart | 0..* | ST | The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6) | |
| FormulationPart | 0..* | ST | The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7) | |
| IntendedUsePart | 0..* | ST | The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8) | |
| TargetPopulationPart | 0..* | ST | The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9) | |
| ContainerOrPackPart | 0..* | ST | The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10) | |
| DevicePart | 0..* | ST | The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11) | |
| TrademarkOrCompanyNamePart | 0..* | ST | The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12) | |
| Time-PeriodPart | 0..* | ST | The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13) | |
| FlavourPart | 0..* | ST | The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14) | |
| DelimiterPart | 0..* | ST | A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15) | |
| Country-Language | 1..* | Class | 9.2.2.9 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2) | |
| Jurisdiction | 0..1 | CD | The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3) | |
| Language | 1..1 | CD | The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4) | |
| OrphanDesignation | 0..* | Class | 9.2.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OrphanIndicationType | 1..1 | CD | This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2) | |
| OrphanProcedureNumber | 0..1 | II | This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3) | |
| OrphanDesignationAuthorisationStatus | 1..1 | CD | This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4) | |
| OrphanDesignationAuthorisationDate | 0..1 | DT | This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5) | |
| OrphanDesignationNumber | 0..1 | II | This field is to indicate the orphan designation decision number. (9.2.2.3.6) | |
| PackagedMedicinalProduct | 1..* | Class | 9.6.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| PCID | 1..1 | II | This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1) | |
| PackageDescription | 1..1 | ST | A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2) | |
| BatchIdentifier | 0..* | Class | 9.6.2.8 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| BAID1 | 1..1 | II | The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1) | |
| BAID2 | 0..1 | II | The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2) | |
| ExpirationDate | 1..1 | DT | This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MarketingAuthorisation | 0..1 | Class | 9.3.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| MarketingAuthorisationNumber | 1..1 | II | The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2) | |
| Country | 1..* | CD | The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3) | |
| LegalStatusOfSupply | 1..1 | CD | The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4) | |
| AuthorisationStatus | 1..1 | CD | The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5) | |
| AuthorisationStatusDate | 1..1 | DT | The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6) | |
| ValidityPeriodStart | 1..1 | DT | The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7) | |
| ValidityPeriodEnd | 1..1 | DT | The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8) | |
| DataExclusivityStartDate | 0..1 | DT | The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9) | |
| DataExclusivityEndDate | 0..1 | DT | The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10) | |
| DateOfFirstAuthorisation | 0..1 | DT | The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11) | |
| InternationalBirthDate | 1..1 | DT | This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12) | |
| JurisdictionalMarketingAuthorisation | 0..* | Class | 9.3.2.10 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2) | |
| Jurisdiction | 0..1 | CD | This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3) | |
| MarketingAuthorisationNumber | 0..1 | II | The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4) | |
| LegalStatusOfSupply | 0..1 | CD | The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5) | |
| MarketingAuthorisationHolder_Organisation | 1..1 | Class | 9.3.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SME | 0..1 | Class | 9.3.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SMEFlag | 1..1 | BL | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) | |
| Size | 0..1 | CD | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) | |
| SMENumber | 0..1 | II | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) | |
| StatusDate | 0..1 | DT | This is the date when the SME status was granted. (9.3.2.4.4) | |
| MarketingAuthorisationProcedure | 1..1 | Class | 9.3.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ProcedureIdentifier-Number | 0..1 | II | The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2) | |
| ProcedureType | 1..1 | CD | The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3) | |
| ProcedureDateStart | 0..1 | DT | The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4) | |
| ProcedureDateEnd | 0..1 | DT | The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5) | |
| MarketingAuthorisationApplication | 0..* | Class | 9.3.2.7 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ApplicationIdentifier-Number | 1..1 | II | A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2) | |
| ApplicationType | 1..1 | CD | The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3) | |
| ApplicationDate | 1..1 | DT | The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4) | |
| MedicinesRegulatoryAgency_Organisation | 1..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MarketingStatus | 0..* | Class | 9.3.2.8 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2) | |
| Jurisdiction | 0..1 | CD | Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3) | |
| MarketingStatus | 1..1 | CD | This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4) | |
| MarketingDateStart | 1..1 | DT | The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5) | |
| MarketingDateStop | 1..1 | DT | The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6) | |
| RiskOfSupplyShortage | 0..1 | BL | Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7) | |
| RiskOfSupplyShortageComment | 0..1 | ST | Any additional comment on supply shortage. (9.3.2.8.8) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| PackageItem_Container | 1..* | Class | 9.6.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| PackageItem_ContainerType | 1..1 | CD | The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2) | |
| PackageItem_ContainerQuantity | 1..1 | PQ | The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3) | |
| Material | 1..* | CD | The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4) | |
| AlternateMaterial | 0..* | CD | The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5) | |
| DataCarrierIdentifier | 0..* | Class | 9.6.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2) | |
| Value | 1..1 | CD | The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3) | |
| Device | 0..* | Class | 9.6.2.12 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| DeviceType | 1..1 | CD | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) | |
| DeviceTradeName | 0..1 | ST | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) | |
| DeviceQuantity | 1..1 | PQ | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) | |
| DeviceListingNumber | 0..1 | ST | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) | |
| DeviceIdentifier | 0..1 | II | A unique device identifier needs to be specified. (9.6.2.12.6) | |
| ModelNumber | 0..1 | ST | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) | |
| SterilityIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) | |
| SterilisationRequirementIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) | |
| DeviceUsage | 0..1 | CD | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) | |
| DeviceBatchIdentifier | 0..* | Class | 9.6.2.15 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| BatchNumber | 1..1 | ST | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) | |
| ExpirationDate | 1..1 | DT | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) | |
| DeviceMaterial | 0..* | Class | 9.6.2.13 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) | |
| Alternate | 0..1 | BL | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) | |
| DeviceNomenclature | 0..* | Class | 9.6.2.14 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) | |
| Value | 1..1 | CD | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| ManufacturedItem | 0..* | Class | 9.6.2.20 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ManufacturedDoseForm | 1..1 | CD | This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2) | |
| UnitOfPresentation | 0..1 | CD | This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3) | |
| ManufacturedItemQuantity | 1..1 | PQ | The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4) | |
| Ingredient | 1..* | Class | 9.7.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IngredientRole | 1..1 | CD | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SpecifiedSubstance | 0..* | Class | 9.7.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SpecifiedSubstance | 1..1 | CD | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) | |
| SpecifiedSubstanceGroup | 1..1 | CD | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) | |
| Strength | 0..* | Class | 9.7.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Substance | 0..1 | Class | 9.7.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) | |
| Strength | 1..* | Class | 9.7.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| Package_Component | 0..* | Class | 9.6.2.9 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ComponentType | 1..1 | CD | The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2) | |
| ComponentMaterial | 0..* | CD | The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3) | |
| ComponentAlternateMaterial | 0..* | CD | Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| PharmaceuticalProduct | 1..* | Class | 9.8.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| AdministrableDoseForm | 1..1 | CD | This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2) | |
| UnitOfPresentation | 0..1 | CD | The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3) | |
| Device | 0..* | Class | 9.6.2.12 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| DeviceType | 1..1 | CD | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) | |
| DeviceTradeName | 0..1 | ST | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) | |
| DeviceQuantity | 1..1 | PQ | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) | |
| DeviceListingNumber | 0..1 | ST | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) | |
| DeviceIdentifier | 0..1 | II | A unique device identifier needs to be specified. (9.6.2.12.6) | |
| ModelNumber | 0..1 | ST | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) | |
| SterilityIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) | |
| SterilisationRequirementIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) | |
| DeviceUsage | 0..1 | CD | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) | |
| DeviceBatchIdentifier | 0..* | Class | 9.6.2.15 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| BatchNumber | 1..1 | ST | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) | |
| ExpirationDate | 1..1 | DT | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) | |
| DeviceMaterial | 0..* | Class | 9.6.2.13 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) | |
| Alternate | 0..1 | BL | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) | |
| DeviceNomenclature | 0..* | Class | 9.6.2.14 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) | |
| Value | 1..1 | CD | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| Ingredient | 1..* | Class | 9.7.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IngredientRole | 1..1 | CD | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SpecifiedSubstance | 0..* | Class | 9.7.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SpecifiedSubstance | 1..1 | CD | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) | |
| SpecifiedSubstanceGroup | 1..1 | CD | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) | |
| Strength | 0..* | Class | 9.7.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Substance | 0..1 | Class | 9.7.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) | |
| Strength | 1..* | Class | 9.7.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| PharmaceuticalProductCharacteristics | 0..* | Class | 9.8.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2) | |
| Value | 1..1 | CD | The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3) | |
| Status | 0..1 | CD | The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4) | |
| PhPIDSet | 1..* | Class | 9.8.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| PhPIDIdentifierSets | 1..1 | II | This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0) | |
| RouteOfAdministration | 1..* | Class | 9.8.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| RouteOfAdministration | 1..1 | CD | The route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0) | |
| ProductClassification | 0..* | Class | 9.2.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2) | |
| Value | 1..1 | CD | The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3) | |
| ProductCross-Reference | 0..* | Class | 9.2.2.7 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| I_MPIDCross-Reference | 1..1 | II | This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2) | |
| ReferencedProductType | 0..1 | CD | This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3) | |
| TherapeuticIndication | 1..* | Class | 9.9.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IndicationText | 1..1 | ST | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) | |
| IndicationAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) | |
| Comorbidity | 0..* | CD | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) | |
| IntendedEffect | 0..1 | CD | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) | |
| Timing-Duration | 0..1 | PQ | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 1..* | Class | 9.9.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| Documentation for this format | ||||
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| MedicinalProduct | 0..* | Base | Instances of this logical model are not marked to be the target of a Reference | |
| MPID | 1..1 | II | This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2) | |
| CombinedPharmaceuticalDoseForm | 0..1 | CD | The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3) | |
| AdditionalMonitoringIndicator | 0..1 | CD | If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4) | |
| SpecialMeasures | 0..* | ST | If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5) | |
| PaediatricUseIndicator | 0..1 | CD | This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6) | |
| OrphanDesignationStatus | 0..1 | CD | The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7) | |
| AttachedDocument | 1..* | Class | 9.2.2.11 | |
 @id | 0..1 | string | Unique id for inter-element referencing | |
 extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2) | |
| EffectiveDate | 1..1 | DT | The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3) | |
| Type | 1..1 | CD | The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4) | |
| Content | 1..1 | ED | The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5) | |
| Language | 0..1 | CD | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6) | |
| MediaType | 0..1 | CD | This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7) | |
| VersionNumber | 0..1 | ST | This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8) | |
| VersionSetIdentifier | 0..1 | II | This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9) | |
| Contraindication | 0..* | Class | 9.9.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ContraindicationsText | 1..1 | ST | The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2) | |
| ContraindicationsAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4) | |
| Comorbidity | 0..* | CD | The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| TherapeuticIndication | 0..* | Class | 9.9.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IndicationText | 1..1 | ST | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) | |
| IndicationAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) | |
| Comorbidity | 0..* | CD | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) | |
| IntendedEffect | 0..1 | CD | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) | |
| Timing-Duration | 0..1 | PQ | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 1..* | Class | 9.9.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| Header | 1..1 | Class | 9.2.2.10 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2) | |
| EffectiveDate | 1..1 | DT | The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3) | |
| Language | 0..1 | CD | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4) | |
| VersionNumber | 0..1 | ST | This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5) | |
| VersionSetIdentifier | 0..1 | II | This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6) | |
| Interactions | 0..* | Class | 9.9.2.7 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| InteractionsText | 1..1 | ST | The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2) | |
| Interactant | 0..* | CD | This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3) | |
| InteractionsType | 0..1 | CD | The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4) | |
| InteractionsEffect | 0..1 | CD | The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5) | |
| InteractionsIncidence | 0..1 | CD | The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6) | |
| ManagementActions | 0..1 | CD | The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7) | |
| Manufacturer-Establishment_Organisation | 1..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MarketingAuthorisation | 1..1 | Class | 9.3.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| MarketingAuthorisationNumber | 1..1 | II | The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2) | |
| Country | 1..* | CD | The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3) | |
| LegalStatusOfSupply | 1..1 | CD | The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4) | |
| AuthorisationStatus | 1..1 | CD | The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5) | |
| AuthorisationStatusDate | 1..1 | DT | The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6) | |
| ValidityPeriodStart | 1..1 | DT | The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7) | |
| ValidityPeriodEnd | 1..1 | DT | The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8) | |
| DataExclusivityStartDate | 0..1 | DT | The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9) | |
| DataExclusivityEndDate | 0..1 | DT | The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10) | |
| DateOfFirstAuthorisation | 0..1 | DT | The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11) | |
| InternationalBirthDate | 1..1 | DT | This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12) | |
| JurisdictionalMarketingAuthorisation | 0..* | Class | 9.3.2.10 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2) | |
| Jurisdiction | 0..1 | CD | This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3) | |
| MarketingAuthorisationNumber | 0..1 | II | The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4) | |
| LegalStatusOfSupply | 0..1 | CD | The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5) | |
| MarketingAuthorisationHolder_Organisation | 1..1 | Class | 9.3.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SME | 0..1 | Class | 9.3.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SMEFlag | 1..1 | BL | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) | |
| Size | 0..1 | CD | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) | |
| SMENumber | 0..1 | II | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) | |
| StatusDate | 0..1 | DT | This is the date when the SME status was granted. (9.3.2.4.4) | |
| MarketingAuthorisationProcedure | 1..1 | Class | 9.3.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ProcedureIdentifier-Number | 0..1 | II | The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2) | |
| ProcedureType | 1..1 | CD | The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3) | |
| ProcedureDateStart | 0..1 | DT | The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4) | |
| ProcedureDateEnd | 0..1 | DT | The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5) | |
| MarketingAuthorisationApplication | 0..* | Class | 9.3.2.7 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ApplicationIdentifier-Number | 1..1 | II | A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2) | |
| ApplicationType | 1..1 | CD | The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3) | |
| ApplicationDate | 1..1 | DT | The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4) | |
| MedicinesRegulatoryAgency_Organisation | 1..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MarketingStatus | 0..* | Class | 9.3.2.8 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2) | |
| Jurisdiction | 0..1 | CD | Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3) | |
| MarketingStatus | 1..1 | CD | This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4) | |
| MarketingDateStart | 1..1 | DT | The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5) | |
| MarketingDateStop | 1..1 | DT | The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6) | |
| RiskOfSupplyShortage | 0..1 | BL | Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7) | |
| RiskOfSupplyShortageComment | 0..1 | ST | Any additional comment on supply shortage. (9.3.2.8.8) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MasterFile | 0..* | Class | 9.2.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| FileType | 1..1 | CD | This attribute is to define which kind of master file is indicated (9.2.2.5.2) | |
| FileCode | 1..1 | II | This attribute is for a code to uniquely identify a master file. (9.2.2.5.3) | |
| MasterFileHolder_Organisation | 0..1 | Class | 9.2.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MedicinalProductName | 1..* | Class | 9.2.2.8 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| FullName | 1..1 | ST | The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2) | |
| InventedNamePart | 0..* | ST | The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3) | |
| ScientificNamePart | 0..* | ST | The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4) | |
| StrengthPart | 0..* | ST | The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5) | |
| PharmaceuticalDoseFormPart | 0..* | ST | The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6) | |
| FormulationPart | 0..* | ST | The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7) | |
| IntendedUsePart | 0..* | ST | The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8) | |
| TargetPopulationPart | 0..* | ST | The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9) | |
| ContainerOrPackPart | 0..* | ST | The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10) | |
| DevicePart | 0..* | ST | The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11) | |
| TrademarkOrCompanyNamePart | 0..* | ST | The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12) | |
| Time-PeriodPart | 0..* | ST | The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13) | |
| FlavourPart | 0..* | ST | The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14) | |
| DelimiterPart | 0..* | ST | A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15) | |
| Country-Language | 1..* | Class | 9.2.2.9 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2) | |
| Jurisdiction | 0..1 | CD | The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3) | |
| Language | 1..1 | CD | The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4) | |
| OrphanDesignation | 0..* | Class | 9.2.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OrphanIndicationType | 1..1 | CD | This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2) | |
| OrphanProcedureNumber | 0..1 | II | This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3) | |
| OrphanDesignationAuthorisationStatus | 1..1 | CD | This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4) | |
| OrphanDesignationAuthorisationDate | 0..1 | DT | This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5) | |
| OrphanDesignationNumber | 0..1 | II | This field is to indicate the orphan designation decision number. (9.2.2.3.6) | |
| PackagedMedicinalProduct | 1..* | Class | 9.6.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| PCID | 1..1 | II | This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1) | |
| PackageDescription | 1..1 | ST | A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2) | |
| BatchIdentifier | 0..* | Class | 9.6.2.8 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| BAID1 | 1..1 | II | The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1) | |
| BAID2 | 0..1 | II | The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2) | |
| ExpirationDate | 1..1 | DT | This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MarketingAuthorisation | 0..1 | Class | 9.3.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| MarketingAuthorisationNumber | 1..1 | II | The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2) | |
| Country | 1..* | CD | The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3) | |
| LegalStatusOfSupply | 1..1 | CD | The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4) | |
| AuthorisationStatus | 1..1 | CD | The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5) | |
| AuthorisationStatusDate | 1..1 | DT | The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6) | |
| ValidityPeriodStart | 1..1 | DT | The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7) | |
| ValidityPeriodEnd | 1..1 | DT | The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8) | |
| DataExclusivityStartDate | 0..1 | DT | The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9) | |
| DataExclusivityEndDate | 0..1 | DT | The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10) | |
| DateOfFirstAuthorisation | 0..1 | DT | The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11) | |
| InternationalBirthDate | 1..1 | DT | This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12) | |
| JurisdictionalMarketingAuthorisation | 0..* | Class | 9.3.2.10 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2) | |
| Jurisdiction | 0..1 | CD | This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3) | |
| MarketingAuthorisationNumber | 0..1 | II | The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4) | |
| LegalStatusOfSupply | 0..1 | CD | The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5) | |
| MarketingAuthorisationHolder_Organisation | 1..1 | Class | 9.3.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SME | 0..1 | Class | 9.3.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SMEFlag | 1..1 | BL | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) | |
| Size | 0..1 | CD | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) | |
| SMENumber | 0..1 | II | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) | |
| StatusDate | 0..1 | DT | This is the date when the SME status was granted. (9.3.2.4.4) | |
| MarketingAuthorisationProcedure | 1..1 | Class | 9.3.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ProcedureIdentifier-Number | 0..1 | II | The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2) | |
| ProcedureType | 1..1 | CD | The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3) | |
| ProcedureDateStart | 0..1 | DT | The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4) | |
| ProcedureDateEnd | 0..1 | DT | The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5) | |
| MarketingAuthorisationApplication | 0..* | Class | 9.3.2.7 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ApplicationIdentifier-Number | 1..1 | II | A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2) | |
| ApplicationType | 1..1 | CD | The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3) | |
| ApplicationDate | 1..1 | DT | The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4) | |
| MedicinesRegulatoryAgency_Organisation | 1..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MarketingStatus | 0..* | Class | 9.3.2.8 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2) | |
| Jurisdiction | 0..1 | CD | Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3) | |
| MarketingStatus | 1..1 | CD | This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4) | |
| MarketingDateStart | 1..1 | DT | The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5) | |
| MarketingDateStop | 1..1 | DT | The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6) | |
| RiskOfSupplyShortage | 0..1 | BL | Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7) | |
| RiskOfSupplyShortageComment | 0..1 | ST | Any additional comment on supply shortage. (9.3.2.8.8) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| PackageItem_Container | 1..* | Class | 9.6.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| PackageItem_ContainerType | 1..1 | CD | The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2) | |
| PackageItem_ContainerQuantity | 1..1 | PQ | The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3) | |
| Material | 1..* | CD | The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4) | |
| AlternateMaterial | 0..* | CD | The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5) | |
| DataCarrierIdentifier | 0..* | Class | 9.6.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2) | |
| Value | 1..1 | CD | The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3) | |
| Device | 0..* | Class | 9.6.2.12 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| DeviceType | 1..1 | CD | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) | |
| DeviceTradeName | 0..1 | ST | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) | |
| DeviceQuantity | 1..1 | PQ | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) | |
| DeviceListingNumber | 0..1 | ST | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) | |
| DeviceIdentifier | 0..1 | II | A unique device identifier needs to be specified. (9.6.2.12.6) | |
| ModelNumber | 0..1 | ST | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) | |
| SterilityIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) | |
| SterilisationRequirementIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) | |
| DeviceUsage | 0..1 | CD | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) | |
| DeviceBatchIdentifier | 0..* | Class | 9.6.2.15 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| BatchNumber | 1..1 | ST | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) | |
| ExpirationDate | 1..1 | DT | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) | |
| DeviceMaterial | 0..* | Class | 9.6.2.13 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) | |
| Alternate | 0..1 | BL | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) | |
| DeviceNomenclature | 0..* | Class | 9.6.2.14 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) | |
| Value | 1..1 | CD | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| ManufacturedItem | 0..* | Class | 9.6.2.20 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ManufacturedDoseForm | 1..1 | CD | This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2) | |
| UnitOfPresentation | 0..1 | CD | This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3) | |
| ManufacturedItemQuantity | 1..1 | PQ | The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4) | |
| Ingredient | 1..* | Class | 9.7.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IngredientRole | 1..1 | CD | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SpecifiedSubstance | 0..* | Class | 9.7.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SpecifiedSubstance | 1..1 | CD | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) | |
| SpecifiedSubstanceGroup | 1..1 | CD | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) | |
| Strength | 0..* | Class | 9.7.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Substance | 0..1 | Class | 9.7.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) | |
| Strength | 1..* | Class | 9.7.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| Package_Component | 0..* | Class | 9.6.2.9 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ComponentType | 1..1 | CD | The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2) | |
| ComponentMaterial | 0..* | CD | The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3) | |
| ComponentAlternateMaterial | 0..* | CD | Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| PharmaceuticalProduct | 1..* | Class | 9.8.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| AdministrableDoseForm | 1..1 | CD | This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2) | |
| UnitOfPresentation | 0..1 | CD | The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3) | |
| Device | 0..* | Class | 9.6.2.12 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| DeviceType | 1..1 | CD | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) | |
| DeviceTradeName | 0..1 | ST | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) | |
| DeviceQuantity | 1..1 | PQ | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) | |
| DeviceListingNumber | 0..1 | ST | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) | |
| DeviceIdentifier | 0..1 | II | A unique device identifier needs to be specified. (9.6.2.12.6) | |
| ModelNumber | 0..1 | ST | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) | |
| SterilityIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) | |
| SterilisationRequirementIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) | |
| DeviceUsage | 0..1 | CD | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) | |
| DeviceBatchIdentifier | 0..* | Class | 9.6.2.15 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| BatchNumber | 1..1 | ST | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) | |
| ExpirationDate | 1..1 | DT | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) | |
| DeviceMaterial | 0..* | Class | 9.6.2.13 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) | |
| Alternate | 0..1 | BL | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) | |
| DeviceNomenclature | 0..* | Class | 9.6.2.14 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) | |
| Value | 1..1 | CD | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| Ingredient | 1..* | Class | 9.7.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IngredientRole | 1..1 | CD | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SpecifiedSubstance | 0..* | Class | 9.7.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SpecifiedSubstance | 1..1 | CD | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) | |
| SpecifiedSubstanceGroup | 1..1 | CD | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) | |
| Strength | 0..* | Class | 9.7.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Substance | 0..1 | Class | 9.7.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) | |
| Strength | 1..* | Class | 9.7.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| PharmaceuticalProductCharacteristics | 0..* | Class | 9.8.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2) | |
| Value | 1..1 | CD | The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3) | |
| Status | 0..1 | CD | The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4) | |
| PhPIDSet | 1..* | Class | 9.8.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| PhPIDIdentifierSets | 1..1 | II | This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0) | |
| RouteOfAdministration | 1..* | Class | 9.8.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| RouteOfAdministration | 1..1 | CD | The route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0) | |
| ProductClassification | 0..* | Class | 9.2.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2) | |
| Value | 1..1 | CD | The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3) | |
| ProductCross-Reference | 0..* | Class | 9.2.2.7 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| I_MPIDCross-Reference | 1..1 | II | This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2) | |
| ReferencedProductType | 0..1 | CD | This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3) | |
| TherapeuticIndication | 1..* | Class | 9.9.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IndicationText | 1..1 | ST | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) | |
| IndicationAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) | |
| Comorbidity | 0..* | CD | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) | |
| IntendedEffect | 0..1 | CD | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) | |
| Timing-Duration | 0..1 | PQ | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 1..* | Class | 9.9.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| Documentation for this format | ||||
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Base
Summary
Mandatory: 0 element (353 nested mandatory elements)
Structures
This structure refers to these other structures:
Differential View
This structure is derived from Base
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| MedicinalProduct | 0..* | Base | Instances of this logical model are not marked to be the target of a Reference | |
| MPID | 1..1 | II | This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2) | |
| CombinedPharmaceuticalDoseForm | 0..1 | CD | The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3) | |
| AdditionalMonitoringIndicator | 0..1 | CD | If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4) | |
| SpecialMeasures | 0..* | ST | If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5) | |
| PaediatricUseIndicator | 0..1 | CD | This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6) | |
| OrphanDesignationStatus | 0..1 | CD | The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7) | |
| AttachedDocument | 1..* | Class | 9.2.2.11 | |
| Identifier | 1..1 | II | The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2) | |
| EffectiveDate | 1..1 | DT | The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3) | |
| Type | 1..1 | CD | The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4) | |
| Content | 1..1 | ED | The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5) | |
| Language | 0..1 | CD | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6) | |
| MediaType | 0..1 | CD | This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7) | |
| VersionNumber | 0..1 | ST | This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8) | |
| VersionSetIdentifier | 0..1 | II | This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9) | |
| Contraindication | 0..* | Class | 9.9.2.3 | |
| ContraindicationsText | 1..1 | ST | The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2) | |
| ContraindicationsAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4) | |
| Comorbidity | 0..* | CD | The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| TherapeuticIndication | 0..* | Class | 9.9.2.2 | |
| IndicationText | 1..1 | ST | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) | |
| IndicationAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) | |
| Comorbidity | 0..* | CD | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) | |
| IntendedEffect | 0..1 | CD | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) | |
| Timing-Duration | 0..1 | PQ | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 1..* | Class | 9.9.2.5 | |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| Header | 1..1 | Class | 9.2.2.10 | |
| Identifier | 1..1 | II | This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2) | |
| EffectiveDate | 1..1 | DT | The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3) | |
| Language | 0..1 | CD | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4) | |
| VersionNumber | 0..1 | ST | This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5) | |
| VersionSetIdentifier | 0..1 | II | This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6) | |
| Interactions | 0..* | Class | 9.9.2.7 | |
| InteractionsText | 1..1 | ST | The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2) | |
| Interactant | 0..* | CD | This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3) | |
| InteractionsType | 0..1 | CD | The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4) | |
| InteractionsEffect | 0..1 | CD | The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5) | |
| InteractionsIncidence | 0..1 | CD | The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6) | |
| ManagementActions | 0..1 | CD | The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7) | |
| Manufacturer-Establishment_Organisation | 1..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MarketingAuthorisation | 1..1 | Class | 9.3.2.2 | |
| MarketingAuthorisationNumber | 1..1 | II | The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2) | |
| Country | 1..* | CD | The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3) | |
| LegalStatusOfSupply | 1..1 | CD | The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4) | |
| AuthorisationStatus | 1..1 | CD | The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5) | |
| AuthorisationStatusDate | 1..1 | DT | The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6) | |
| ValidityPeriodStart | 1..1 | DT | The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7) | |
| ValidityPeriodEnd | 1..1 | DT | The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8) | |
| DataExclusivityStartDate | 0..1 | DT | The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9) | |
| DataExclusivityEndDate | 0..1 | DT | The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10) | |
| DateOfFirstAuthorisation | 0..1 | DT | The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11) | |
| InternationalBirthDate | 1..1 | DT | This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12) | |
| JurisdictionalMarketingAuthorisation | 0..* | Class | 9.3.2.10 | |
| Country | 1..1 | CD | This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2) | |
| Jurisdiction | 0..1 | CD | This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3) | |
| MarketingAuthorisationNumber | 0..1 | II | The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4) | |
| LegalStatusOfSupply | 0..1 | CD | The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5) | |
| MarketingAuthorisationHolder_Organisation | 1..1 | Class | 9.3.2.3 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SME | 0..1 | Class | 9.3.2.4 | |
| SMEFlag | 1..1 | BL | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) | |
| Size | 0..1 | CD | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) | |
| SMENumber | 0..1 | II | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) | |
| StatusDate | 0..1 | DT | This is the date when the SME status was granted. (9.3.2.4.4) | |
| MarketingAuthorisationProcedure | 1..1 | Class | 9.3.2.6 | |
| ProcedureIdentifier-Number | 0..1 | II | The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2) | |
| ProcedureType | 1..1 | CD | The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3) | |
| ProcedureDateStart | 0..1 | DT | The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4) | |
| ProcedureDateEnd | 0..1 | DT | The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5) | |
| MarketingAuthorisationApplication | 0..* | Class | 9.3.2.7 | |
| ApplicationIdentifier-Number | 1..1 | II | A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2) | |
| ApplicationType | 1..1 | CD | The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3) | |
| ApplicationDate | 1..1 | DT | The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4) | |
| MedicinesRegulatoryAgency_Organisation | 1..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MarketingStatus | 0..* | Class | 9.3.2.8 | |
| Country | 1..1 | CD | The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2) | |
| Jurisdiction | 0..1 | CD | Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3) | |
| MarketingStatus | 1..1 | CD | This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4) | |
| MarketingDateStart | 1..1 | DT | The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5) | |
| MarketingDateStop | 1..1 | DT | The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6) | |
| RiskOfSupplyShortage | 0..1 | BL | Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7) | |
| RiskOfSupplyShortageComment | 0..1 | ST | Any additional comment on supply shortage. (9.3.2.8.8) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MasterFile | 0..* | Class | 9.2.2.5 | |
| FileType | 1..1 | CD | This attribute is to define which kind of master file is indicated (9.2.2.5.2) | |
| FileCode | 1..1 | II | This attribute is for a code to uniquely identify a master file. (9.2.2.5.3) | |
| MasterFileHolder_Organisation | 0..1 | Class | 9.2.2.6 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MedicinalProductName | 1..* | Class | 9.2.2.8 | |
| FullName | 1..1 | ST | The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2) | |
| InventedNamePart | 0..* | ST | The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3) | |
| ScientificNamePart | 0..* | ST | The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4) | |
| StrengthPart | 0..* | ST | The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5) | |
| PharmaceuticalDoseFormPart | 0..* | ST | The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6) | |
| FormulationPart | 0..* | ST | The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7) | |
| IntendedUsePart | 0..* | ST | The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8) | |
| TargetPopulationPart | 0..* | ST | The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9) | |
| ContainerOrPackPart | 0..* | ST | The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10) | |
| DevicePart | 0..* | ST | The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11) | |
| TrademarkOrCompanyNamePart | 0..* | ST | The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12) | |
| Time-PeriodPart | 0..* | ST | The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13) | |
| FlavourPart | 0..* | ST | The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14) | |
| DelimiterPart | 0..* | ST | A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15) | |
| Country-Language | 1..* | Class | 9.2.2.9 | |
| Country | 1..1 | CD | The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2) | |
| Jurisdiction | 0..1 | CD | The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3) | |
| Language | 1..1 | CD | The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4) | |
| OrphanDesignation | 0..* | Class | 9.2.2.3 | |
| OrphanIndicationType | 1..1 | CD | This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2) | |
| OrphanProcedureNumber | 0..1 | II | This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3) | |
| OrphanDesignationAuthorisationStatus | 1..1 | CD | This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4) | |
| OrphanDesignationAuthorisationDate | 0..1 | DT | This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5) | |
| OrphanDesignationNumber | 0..1 | II | This field is to indicate the orphan designation decision number. (9.2.2.3.6) | |
| PackagedMedicinalProduct | 1..* | Class | 9.6.2.2 | |
| PCID | 1..1 | II | This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1) | |
| PackageDescription | 1..1 | ST | A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2) | |
| BatchIdentifier | 0..* | Class | 9.6.2.8 | |
| BAID1 | 1..1 | II | The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1) | |
| BAID2 | 0..1 | II | The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2) | |
| ExpirationDate | 1..1 | DT | This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MarketingAuthorisation | 0..1 | Class | 9.3.2.2 | |
| MarketingAuthorisationNumber | 1..1 | II | The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2) | |
| Country | 1..* | CD | The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3) | |
| LegalStatusOfSupply | 1..1 | CD | The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4) | |
| AuthorisationStatus | 1..1 | CD | The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5) | |
| AuthorisationStatusDate | 1..1 | DT | The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6) | |
| ValidityPeriodStart | 1..1 | DT | The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7) | |
| ValidityPeriodEnd | 1..1 | DT | The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8) | |
| DataExclusivityStartDate | 0..1 | DT | The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9) | |
| DataExclusivityEndDate | 0..1 | DT | The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10) | |
| DateOfFirstAuthorisation | 0..1 | DT | The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11) | |
| InternationalBirthDate | 1..1 | DT | This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12) | |
| JurisdictionalMarketingAuthorisation | 0..* | Class | 9.3.2.10 | |
| Country | 1..1 | CD | This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2) | |
| Jurisdiction | 0..1 | CD | This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3) | |
| MarketingAuthorisationNumber | 0..1 | II | The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4) | |
| LegalStatusOfSupply | 0..1 | CD | The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5) | |
| MarketingAuthorisationHolder_Organisation | 1..1 | Class | 9.3.2.3 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SME | 0..1 | Class | 9.3.2.4 | |
| SMEFlag | 1..1 | BL | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) | |
| Size | 0..1 | CD | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) | |
| SMENumber | 0..1 | II | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) | |
| StatusDate | 0..1 | DT | This is the date when the SME status was granted. (9.3.2.4.4) | |
| MarketingAuthorisationProcedure | 1..1 | Class | 9.3.2.6 | |
| ProcedureIdentifier-Number | 0..1 | II | The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2) | |
| ProcedureType | 1..1 | CD | The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3) | |
| ProcedureDateStart | 0..1 | DT | The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4) | |
| ProcedureDateEnd | 0..1 | DT | The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5) | |
| MarketingAuthorisationApplication | 0..* | Class | 9.3.2.7 | |
| ApplicationIdentifier-Number | 1..1 | II | A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2) | |
| ApplicationType | 1..1 | CD | The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3) | |
| ApplicationDate | 1..1 | DT | The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4) | |
| MedicinesRegulatoryAgency_Organisation | 1..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MarketingStatus | 0..* | Class | 9.3.2.8 | |
| Country | 1..1 | CD | The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2) | |
| Jurisdiction | 0..1 | CD | Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3) | |
| MarketingStatus | 1..1 | CD | This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4) | |
| MarketingDateStart | 1..1 | DT | The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5) | |
| MarketingDateStop | 1..1 | DT | The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6) | |
| RiskOfSupplyShortage | 0..1 | BL | Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7) | |
| RiskOfSupplyShortageComment | 0..1 | ST | Any additional comment on supply shortage. (9.3.2.8.8) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| PackageItem_Container | 1..* | Class | 9.6.2.3 | |
| PackageItem_ContainerType | 1..1 | CD | The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2) | |
| PackageItem_ContainerQuantity | 1..1 | PQ | The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3) | |
| Material | 1..* | CD | The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4) | |
| AlternateMaterial | 0..* | CD | The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5) | |
| DataCarrierIdentifier | 0..* | Class | 9.6.2.4 | |
| CodeSystem | 1..1 | CD | The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2) | |
| Value | 1..1 | CD | The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3) | |
| Device | 0..* | Class | 9.6.2.12 | |
| DeviceType | 1..1 | CD | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) | |
| DeviceTradeName | 0..1 | ST | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) | |
| DeviceQuantity | 1..1 | PQ | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) | |
| DeviceListingNumber | 0..1 | ST | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) | |
| DeviceIdentifier | 0..1 | II | A unique device identifier needs to be specified. (9.6.2.12.6) | |
| ModelNumber | 0..1 | ST | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) | |
| SterilityIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) | |
| SterilisationRequirementIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) | |
| DeviceUsage | 0..1 | CD | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) | |
| DeviceBatchIdentifier | 0..* | Class | 9.6.2.15 | |
| BatchNumber | 1..1 | ST | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) | |
| ExpirationDate | 1..1 | DT | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) | |
| DeviceMaterial | 0..* | Class | 9.6.2.13 | |
| Substance | 1..1 | CD | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) | |
| Alternate | 0..1 | BL | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) | |
| DeviceNomenclature | 0..* | Class | 9.6.2.14 | |
| CodeSystem | 1..1 | CD | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) | |
| Value | 1..1 | CD | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| ManufacturedItem | 0..* | Class | 9.6.2.20 | |
| ManufacturedDoseForm | 1..1 | CD | This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2) | |
| UnitOfPresentation | 0..1 | CD | This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3) | |
| ManufacturedItemQuantity | 1..1 | PQ | The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4) | |
| Ingredient | 1..* | Class | 9.7.2.2 | |
| IngredientRole | 1..1 | CD | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SpecifiedSubstance | 0..* | Class | 9.7.2.4 | |
| SpecifiedSubstance | 1..1 | CD | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) | |
| SpecifiedSubstanceGroup | 1..1 | CD | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) | |
| Strength | 0..* | Class | 9.7.2.5 | |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Substance | 0..1 | Class | 9.7.2.3 | |
| Substance | 1..1 | CD | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) | |
| Strength | 1..* | Class | 9.7.2.5 | |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| Package_Component | 0..* | Class | 9.6.2.9 | |
| ComponentType | 1..1 | CD | The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2) | |
| ComponentMaterial | 0..* | CD | The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3) | |
| ComponentAlternateMaterial | 0..* | CD | Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| PharmaceuticalProduct | 1..* | Class | 9.8.2.2 | |
| AdministrableDoseForm | 1..1 | CD | This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2) | |
| UnitOfPresentation | 0..1 | CD | The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3) | |
| Device | 0..* | Class | 9.6.2.12 | |
| DeviceType | 1..1 | CD | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) | |
| DeviceTradeName | 0..1 | ST | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) | |
| DeviceQuantity | 1..1 | PQ | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) | |
| DeviceListingNumber | 0..1 | ST | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) | |
| DeviceIdentifier | 0..1 | II | A unique device identifier needs to be specified. (9.6.2.12.6) | |
| ModelNumber | 0..1 | ST | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) | |
| SterilityIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) | |
| SterilisationRequirementIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) | |
| DeviceUsage | 0..1 | CD | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) | |
| DeviceBatchIdentifier | 0..* | Class | 9.6.2.15 | |
| BatchNumber | 1..1 | ST | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) | |
| ExpirationDate | 1..1 | DT | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) | |
| DeviceMaterial | 0..* | Class | 9.6.2.13 | |
| Substance | 1..1 | CD | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) | |
| Alternate | 0..1 | BL | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) | |
| DeviceNomenclature | 0..* | Class | 9.6.2.14 | |
| CodeSystem | 1..1 | CD | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) | |
| Value | 1..1 | CD | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| Ingredient | 1..* | Class | 9.7.2.2 | |
| IngredientRole | 1..1 | CD | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SpecifiedSubstance | 0..* | Class | 9.7.2.4 | |
| SpecifiedSubstance | 1..1 | CD | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) | |
| SpecifiedSubstanceGroup | 1..1 | CD | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) | |
| Strength | 0..* | Class | 9.7.2.5 | |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Substance | 0..1 | Class | 9.7.2.3 | |
| Substance | 1..1 | CD | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) | |
| Strength | 1..* | Class | 9.7.2.5 | |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| PharmaceuticalProductCharacteristics | 0..* | Class | 9.8.2.4 | |
| CodeSystem | 1..1 | CD | The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2) | |
| Value | 1..1 | CD | The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3) | |
| Status | 0..1 | CD | The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4) | |
| PhPIDSet | 1..* | Class | 9.8.2.6 | |
| PhPIDIdentifierSets | 1..1 | II | This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0) | |
| RouteOfAdministration | 1..* | Class | 9.8.2.3 | |
| RouteOfAdministration | 1..1 | CD | The route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0) | |
| ProductClassification | 0..* | Class | 9.2.2.4 | |
| CodeSystem | 1..1 | CD | The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2) | |
| Value | 1..1 | CD | The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3) | |
| ProductCross-Reference | 0..* | Class | 9.2.2.7 | |
| I_MPIDCross-Reference | 1..1 | II | This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2) | |
| ReferencedProductType | 0..1 | CD | This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3) | |
| TherapeuticIndication | 1..* | Class | 9.9.2.2 | |
| IndicationText | 1..1 | ST | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) | |
| IndicationAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) | |
| Comorbidity | 0..* | CD | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) | |
| IntendedEffect | 0..1 | CD | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) | |
| Timing-Duration | 0..1 | PQ | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 1..* | Class | 9.9.2.5 | |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| MedicinalProduct | 0..* | Base | Instances of this logical model are not marked to be the target of a Reference | |
| MPID | 1..1 | II | This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2) | |
| CombinedPharmaceuticalDoseForm | 0..1 | CD | The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3) | |
| AdditionalMonitoringIndicator | 0..1 | CD | If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4) | |
| SpecialMeasures | 0..* | ST | If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5) | |
| PaediatricUseIndicator | 0..1 | CD | This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6) | |
| OrphanDesignationStatus | 0..1 | CD | The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7) | |
| AttachedDocument | 1..* | Class | 9.2.2.11 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2) | |
| EffectiveDate | 1..1 | DT | The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3) | |
| Type | 1..1 | CD | The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4) | |
| Content | 1..1 | ED | The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5) | |
| Language | 0..1 | CD | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6) | |
| MediaType | 0..1 | CD | This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7) | |
| VersionNumber | 0..1 | ST | This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8) | |
| VersionSetIdentifier | 0..1 | II | This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9) | |
| Contraindication | 0..* | Class | 9.9.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ContraindicationsText | 1..1 | ST | The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2) | |
| ContraindicationsAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4) | |
| Comorbidity | 0..* | CD | The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| TherapeuticIndication | 0..* | Class | 9.9.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IndicationText | 1..1 | ST | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) | |
| IndicationAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) | |
| Comorbidity | 0..* | CD | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) | |
| IntendedEffect | 0..1 | CD | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) | |
| Timing-Duration | 0..1 | PQ | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 1..* | Class | 9.9.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| Header | 1..1 | Class | 9.2.2.10 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2) | |
| EffectiveDate | 1..1 | DT | The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3) | |
| Language | 0..1 | CD | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4) | |
| VersionNumber | 0..1 | ST | This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5) | |
| VersionSetIdentifier | 0..1 | II | This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6) | |
| Interactions | 0..* | Class | 9.9.2.7 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| InteractionsText | 1..1 | ST | The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2) | |
| Interactant | 0..* | CD | This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3) | |
| InteractionsType | 0..1 | CD | The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4) | |
| InteractionsEffect | 0..1 | CD | The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5) | |
| InteractionsIncidence | 0..1 | CD | The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6) | |
| ManagementActions | 0..1 | CD | The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7) | |
| Manufacturer-Establishment_Organisation | 1..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MarketingAuthorisation | 1..1 | Class | 9.3.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| MarketingAuthorisationNumber | 1..1 | II | The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2) | |
| Country | 1..* | CD | The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3) | |
| LegalStatusOfSupply | 1..1 | CD | The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4) | |
| AuthorisationStatus | 1..1 | CD | The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5) | |
| AuthorisationStatusDate | 1..1 | DT | The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6) | |
| ValidityPeriodStart | 1..1 | DT | The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7) | |
| ValidityPeriodEnd | 1..1 | DT | The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8) | |
| DataExclusivityStartDate | 0..1 | DT | The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9) | |
| DataExclusivityEndDate | 0..1 | DT | The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10) | |
| DateOfFirstAuthorisation | 0..1 | DT | The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11) | |
| InternationalBirthDate | 1..1 | DT | This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12) | |
| JurisdictionalMarketingAuthorisation | 0..* | Class | 9.3.2.10 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2) | |
| Jurisdiction | 0..1 | CD | This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3) | |
| MarketingAuthorisationNumber | 0..1 | II | The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4) | |
| LegalStatusOfSupply | 0..1 | CD | The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5) | |
| MarketingAuthorisationHolder_Organisation | 1..1 | Class | 9.3.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SME | 0..1 | Class | 9.3.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SMEFlag | 1..1 | BL | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) | |
| Size | 0..1 | CD | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) | |
| SMENumber | 0..1 | II | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) | |
| StatusDate | 0..1 | DT | This is the date when the SME status was granted. (9.3.2.4.4) | |
| MarketingAuthorisationProcedure | 1..1 | Class | 9.3.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ProcedureIdentifier-Number | 0..1 | II | The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2) | |
| ProcedureType | 1..1 | CD | The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3) | |
| ProcedureDateStart | 0..1 | DT | The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4) | |
| ProcedureDateEnd | 0..1 | DT | The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5) | |
| MarketingAuthorisationApplication | 0..* | Class | 9.3.2.7 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ApplicationIdentifier-Number | 1..1 | II | A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2) | |
| ApplicationType | 1..1 | CD | The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3) | |
| ApplicationDate | 1..1 | DT | The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4) | |
| MedicinesRegulatoryAgency_Organisation | 1..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MarketingStatus | 0..* | Class | 9.3.2.8 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2) | |
| Jurisdiction | 0..1 | CD | Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3) | |
| MarketingStatus | 1..1 | CD | This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4) | |
| MarketingDateStart | 1..1 | DT | The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5) | |
| MarketingDateStop | 1..1 | DT | The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6) | |
| RiskOfSupplyShortage | 0..1 | BL | Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7) | |
| RiskOfSupplyShortageComment | 0..1 | ST | Any additional comment on supply shortage. (9.3.2.8.8) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MasterFile | 0..* | Class | 9.2.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| FileType | 1..1 | CD | This attribute is to define which kind of master file is indicated (9.2.2.5.2) | |
| FileCode | 1..1 | II | This attribute is for a code to uniquely identify a master file. (9.2.2.5.3) | |
| MasterFileHolder_Organisation | 0..1 | Class | 9.2.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MedicinalProductName | 1..* | Class | 9.2.2.8 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| FullName | 1..1 | ST | The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2) | |
| InventedNamePart | 0..* | ST | The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3) | |
| ScientificNamePart | 0..* | ST | The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4) | |
| StrengthPart | 0..* | ST | The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5) | |
| PharmaceuticalDoseFormPart | 0..* | ST | The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6) | |
| FormulationPart | 0..* | ST | The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7) | |
| IntendedUsePart | 0..* | ST | The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8) | |
| TargetPopulationPart | 0..* | ST | The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9) | |
| ContainerOrPackPart | 0..* | ST | The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10) | |
| DevicePart | 0..* | ST | The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11) | |
| TrademarkOrCompanyNamePart | 0..* | ST | The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12) | |
| Time-PeriodPart | 0..* | ST | The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13) | |
| FlavourPart | 0..* | ST | The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14) | |
| DelimiterPart | 0..* | ST | A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15) | |
| Country-Language | 1..* | Class | 9.2.2.9 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2) | |
| Jurisdiction | 0..1 | CD | The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3) | |
| Language | 1..1 | CD | The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4) | |
| OrphanDesignation | 0..* | Class | 9.2.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OrphanIndicationType | 1..1 | CD | This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2) | |
| OrphanProcedureNumber | 0..1 | II | This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3) | |
| OrphanDesignationAuthorisationStatus | 1..1 | CD | This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4) | |
| OrphanDesignationAuthorisationDate | 0..1 | DT | This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5) | |
| OrphanDesignationNumber | 0..1 | II | This field is to indicate the orphan designation decision number. (9.2.2.3.6) | |
| PackagedMedicinalProduct | 1..* | Class | 9.6.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| PCID | 1..1 | II | This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1) | |
| PackageDescription | 1..1 | ST | A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2) | |
| BatchIdentifier | 0..* | Class | 9.6.2.8 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| BAID1 | 1..1 | II | The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1) | |
| BAID2 | 0..1 | II | The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2) | |
| ExpirationDate | 1..1 | DT | This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MarketingAuthorisation | 0..1 | Class | 9.3.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| MarketingAuthorisationNumber | 1..1 | II | The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2) | |
| Country | 1..* | CD | The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3) | |
| LegalStatusOfSupply | 1..1 | CD | The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4) | |
| AuthorisationStatus | 1..1 | CD | The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5) | |
| AuthorisationStatusDate | 1..1 | DT | The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6) | |
| ValidityPeriodStart | 1..1 | DT | The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7) | |
| ValidityPeriodEnd | 1..1 | DT | The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8) | |
| DataExclusivityStartDate | 0..1 | DT | The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9) | |
| DataExclusivityEndDate | 0..1 | DT | The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10) | |
| DateOfFirstAuthorisation | 0..1 | DT | The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11) | |
| InternationalBirthDate | 1..1 | DT | This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12) | |
| JurisdictionalMarketingAuthorisation | 0..* | Class | 9.3.2.10 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2) | |
| Jurisdiction | 0..1 | CD | This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3) | |
| MarketingAuthorisationNumber | 0..1 | II | The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4) | |
| LegalStatusOfSupply | 0..1 | CD | The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5) | |
| MarketingAuthorisationHolder_Organisation | 1..1 | Class | 9.3.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SME | 0..1 | Class | 9.3.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SMEFlag | 1..1 | BL | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) | |
| Size | 0..1 | CD | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) | |
| SMENumber | 0..1 | II | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) | |
| StatusDate | 0..1 | DT | This is the date when the SME status was granted. (9.3.2.4.4) | |
| MarketingAuthorisationProcedure | 1..1 | Class | 9.3.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ProcedureIdentifier-Number | 0..1 | II | The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2) | |
| ProcedureType | 1..1 | CD | The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3) | |
| ProcedureDateStart | 0..1 | DT | The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4) | |
| ProcedureDateEnd | 0..1 | DT | The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5) | |
| MarketingAuthorisationApplication | 0..* | Class | 9.3.2.7 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ApplicationIdentifier-Number | 1..1 | II | A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2) | |
| ApplicationType | 1..1 | CD | The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3) | |
| ApplicationDate | 1..1 | DT | The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4) | |
| MedicinesRegulatoryAgency_Organisation | 1..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MarketingStatus | 0..* | Class | 9.3.2.8 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2) | |
| Jurisdiction | 0..1 | CD | Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3) | |
| MarketingStatus | 1..1 | CD | This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4) | |
| MarketingDateStart | 1..1 | DT | The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5) | |
| MarketingDateStop | 1..1 | DT | The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6) | |
| RiskOfSupplyShortage | 0..1 | BL | Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7) | |
| RiskOfSupplyShortageComment | 0..1 | ST | Any additional comment on supply shortage. (9.3.2.8.8) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| PackageItem_Container | 1..* | Class | 9.6.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| PackageItem_ContainerType | 1..1 | CD | The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2) | |
| PackageItem_ContainerQuantity | 1..1 | PQ | The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3) | |
| Material | 1..* | CD | The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4) | |
| AlternateMaterial | 0..* | CD | The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5) | |
| DataCarrierIdentifier | 0..* | Class | 9.6.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2) | |
| Value | 1..1 | CD | The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3) | |
| Device | 0..* | Class | 9.6.2.12 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| DeviceType | 1..1 | CD | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) | |
| DeviceTradeName | 0..1 | ST | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) | |
| DeviceQuantity | 1..1 | PQ | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) | |
| DeviceListingNumber | 0..1 | ST | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) | |
| DeviceIdentifier | 0..1 | II | A unique device identifier needs to be specified. (9.6.2.12.6) | |
| ModelNumber | 0..1 | ST | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) | |
| SterilityIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) | |
| SterilisationRequirementIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) | |
| DeviceUsage | 0..1 | CD | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) | |
| DeviceBatchIdentifier | 0..* | Class | 9.6.2.15 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| BatchNumber | 1..1 | ST | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) | |
| ExpirationDate | 1..1 | DT | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) | |
| DeviceMaterial | 0..* | Class | 9.6.2.13 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) | |
| Alternate | 0..1 | BL | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) | |
| DeviceNomenclature | 0..* | Class | 9.6.2.14 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) | |
| Value | 1..1 | CD | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| ManufacturedItem | 0..* | Class | 9.6.2.20 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ManufacturedDoseForm | 1..1 | CD | This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2) | |
| UnitOfPresentation | 0..1 | CD | This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3) | |
| ManufacturedItemQuantity | 1..1 | PQ | The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4) | |
| Ingredient | 1..* | Class | 9.7.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IngredientRole | 1..1 | CD | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SpecifiedSubstance | 0..* | Class | 9.7.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SpecifiedSubstance | 1..1 | CD | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) | |
| SpecifiedSubstanceGroup | 1..1 | CD | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) | |
| Strength | 0..* | Class | 9.7.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Substance | 0..1 | Class | 9.7.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) | |
| Strength | 1..* | Class | 9.7.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| Package_Component | 0..* | Class | 9.6.2.9 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ComponentType | 1..1 | CD | The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2) | |
| ComponentMaterial | 0..* | CD | The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3) | |
| ComponentAlternateMaterial | 0..* | CD | Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| PharmaceuticalProduct | 1..* | Class | 9.8.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| AdministrableDoseForm | 1..1 | CD | This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2) | |
| UnitOfPresentation | 0..1 | CD | The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3) | |
| Device | 0..* | Class | 9.6.2.12 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| DeviceType | 1..1 | CD | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) | |
| DeviceTradeName | 0..1 | ST | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) | |
| DeviceQuantity | 1..1 | PQ | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) | |
| DeviceListingNumber | 0..1 | ST | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) | |
| DeviceIdentifier | 0..1 | II | A unique device identifier needs to be specified. (9.6.2.12.6) | |
| ModelNumber | 0..1 | ST | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) | |
| SterilityIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) | |
| SterilisationRequirementIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) | |
| DeviceUsage | 0..1 | CD | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) | |
| DeviceBatchIdentifier | 0..* | Class | 9.6.2.15 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| BatchNumber | 1..1 | ST | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) | |
| ExpirationDate | 1..1 | DT | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) | |
| DeviceMaterial | 0..* | Class | 9.6.2.13 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) | |
| Alternate | 0..1 | BL | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) | |
| DeviceNomenclature | 0..* | Class | 9.6.2.14 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) | |
| Value | 1..1 | CD | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| Ingredient | 1..* | Class | 9.7.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IngredientRole | 1..1 | CD | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SpecifiedSubstance | 0..* | Class | 9.7.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SpecifiedSubstance | 1..1 | CD | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) | |
| SpecifiedSubstanceGroup | 1..1 | CD | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) | |
| Strength | 0..* | Class | 9.7.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Substance | 0..1 | Class | 9.7.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) | |
| Strength | 1..* | Class | 9.7.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| PharmaceuticalProductCharacteristics | 0..* | Class | 9.8.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2) | |
| Value | 1..1 | CD | The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3) | |
| Status | 0..1 | CD | The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4) | |
| PhPIDSet | 1..* | Class | 9.8.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| PhPIDIdentifierSets | 1..1 | II | This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0) | |
| RouteOfAdministration | 1..* | Class | 9.8.2.3 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| RouteOfAdministration | 1..1 | CD | The route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0) | |
| ProductClassification | 0..* | Class | 9.2.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2) | |
| Value | 1..1 | CD | The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3) | |
| ProductCross-Reference | 0..* | Class | 9.2.2.7 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| I_MPIDCross-Reference | 1..1 | II | This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2) | |
| ReferencedProductType | 0..1 | CD | This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3) | |
| TherapeuticIndication | 1..* | Class | 9.9.2.2 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IndicationText | 1..1 | ST | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) | |
| IndicationAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) | |
| Comorbidity | 0..* | CD | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) | |
| IntendedEffect | 0..1 | CD | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) | |
| Timing-Duration | 0..1 | PQ | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 1..* | Class | 9.9.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| Documentation for this format | ||||
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| MedicinalProduct | 0..* | Base | Instances of this logical model are not marked to be the target of a Reference | |
| MPID | 1..1 | II | This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2) | |
| CombinedPharmaceuticalDoseForm | 0..1 | CD | The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3) | |
| AdditionalMonitoringIndicator | 0..1 | CD | If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4) | |
| SpecialMeasures | 0..* | ST | If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5) | |
| PaediatricUseIndicator | 0..1 | CD | This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6) | |
| OrphanDesignationStatus | 0..1 | CD | The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7) | |
| AttachedDocument | 1..* | Class | 9.2.2.11 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2) | |
| EffectiveDate | 1..1 | DT | The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3) | |
| Type | 1..1 | CD | The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4) | |
| Content | 1..1 | ED | The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5) | |
| Language | 0..1 | CD | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6) | |
| MediaType | 0..1 | CD | This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7) | |
| VersionNumber | 0..1 | ST | This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8) | |
| VersionSetIdentifier | 0..1 | II | This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9) | |
| Contraindication | 0..* | Class | 9.9.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ContraindicationsText | 1..1 | ST | The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2) | |
| ContraindicationsAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4) | |
| Comorbidity | 0..* | CD | The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| TherapeuticIndication | 0..* | Class | 9.9.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IndicationText | 1..1 | ST | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) | |
| IndicationAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) | |
| Comorbidity | 0..* | CD | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) | |
| IntendedEffect | 0..1 | CD | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) | |
| Timing-Duration | 0..1 | PQ | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 1..* | Class | 9.9.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| Header | 1..1 | Class | 9.2.2.10 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2) | |
| EffectiveDate | 1..1 | DT | The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3) | |
| Language | 0..1 | CD | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4) | |
| VersionNumber | 0..1 | ST | This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5) | |
| VersionSetIdentifier | 0..1 | II | This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6) | |
| Interactions | 0..* | Class | 9.9.2.7 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| InteractionsText | 1..1 | ST | The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2) | |
| Interactant | 0..* | CD | This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3) | |
| InteractionsType | 0..1 | CD | The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4) | |
| InteractionsEffect | 0..1 | CD | The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5) | |
| InteractionsIncidence | 0..1 | CD | The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6) | |
| ManagementActions | 0..1 | CD | The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7) | |
| Manufacturer-Establishment_Organisation | 1..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MarketingAuthorisation | 1..1 | Class | 9.3.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| MarketingAuthorisationNumber | 1..1 | II | The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2) | |
| Country | 1..* | CD | The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3) | |
| LegalStatusOfSupply | 1..1 | CD | The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4) | |
| AuthorisationStatus | 1..1 | CD | The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5) | |
| AuthorisationStatusDate | 1..1 | DT | The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6) | |
| ValidityPeriodStart | 1..1 | DT | The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7) | |
| ValidityPeriodEnd | 1..1 | DT | The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8) | |
| DataExclusivityStartDate | 0..1 | DT | The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9) | |
| DataExclusivityEndDate | 0..1 | DT | The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10) | |
| DateOfFirstAuthorisation | 0..1 | DT | The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11) | |
| InternationalBirthDate | 1..1 | DT | This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12) | |
| JurisdictionalMarketingAuthorisation | 0..* | Class | 9.3.2.10 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2) | |
| Jurisdiction | 0..1 | CD | This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3) | |
| MarketingAuthorisationNumber | 0..1 | II | The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4) | |
| LegalStatusOfSupply | 0..1 | CD | The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5) | |
| MarketingAuthorisationHolder_Organisation | 1..1 | Class | 9.3.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SME | 0..1 | Class | 9.3.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SMEFlag | 1..1 | BL | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) | |
| Size | 0..1 | CD | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) | |
| SMENumber | 0..1 | II | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) | |
| StatusDate | 0..1 | DT | This is the date when the SME status was granted. (9.3.2.4.4) | |
| MarketingAuthorisationProcedure | 1..1 | Class | 9.3.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ProcedureIdentifier-Number | 0..1 | II | The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2) | |
| ProcedureType | 1..1 | CD | The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3) | |
| ProcedureDateStart | 0..1 | DT | The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4) | |
| ProcedureDateEnd | 0..1 | DT | The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5) | |
| MarketingAuthorisationApplication | 0..* | Class | 9.3.2.7 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ApplicationIdentifier-Number | 1..1 | II | A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2) | |
| ApplicationType | 1..1 | CD | The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3) | |
| ApplicationDate | 1..1 | DT | The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4) | |
| MedicinesRegulatoryAgency_Organisation | 1..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MarketingStatus | 0..* | Class | 9.3.2.8 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2) | |
| Jurisdiction | 0..1 | CD | Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3) | |
| MarketingStatus | 1..1 | CD | This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4) | |
| MarketingDateStart | 1..1 | DT | The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5) | |
| MarketingDateStop | 1..1 | DT | The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6) | |
| RiskOfSupplyShortage | 0..1 | BL | Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7) | |
| RiskOfSupplyShortageComment | 0..1 | ST | Any additional comment on supply shortage. (9.3.2.8.8) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MasterFile | 0..* | Class | 9.2.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| FileType | 1..1 | CD | This attribute is to define which kind of master file is indicated (9.2.2.5.2) | |
| FileCode | 1..1 | II | This attribute is for a code to uniquely identify a master file. (9.2.2.5.3) | |
| MasterFileHolder_Organisation | 0..1 | Class | 9.2.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MedicinalProductName | 1..* | Class | 9.2.2.8 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| FullName | 1..1 | ST | The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2) | |
| InventedNamePart | 0..* | ST | The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3) | |
| ScientificNamePart | 0..* | ST | The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4) | |
| StrengthPart | 0..* | ST | The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5) | |
| PharmaceuticalDoseFormPart | 0..* | ST | The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6) | |
| FormulationPart | 0..* | ST | The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7) | |
| IntendedUsePart | 0..* | ST | The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8) | |
| TargetPopulationPart | 0..* | ST | The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9) | |
| ContainerOrPackPart | 0..* | ST | The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10) | |
| DevicePart | 0..* | ST | The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11) | |
| TrademarkOrCompanyNamePart | 0..* | ST | The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12) | |
| Time-PeriodPart | 0..* | ST | The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13) | |
| FlavourPart | 0..* | ST | The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14) | |
| DelimiterPart | 0..* | ST | A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15) | |
| Country-Language | 1..* | Class | 9.2.2.9 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2) | |
| Jurisdiction | 0..1 | CD | The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3) | |
| Language | 1..1 | CD | The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4) | |
| OrphanDesignation | 0..* | Class | 9.2.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OrphanIndicationType | 1..1 | CD | This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2) | |
| OrphanProcedureNumber | 0..1 | II | This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3) | |
| OrphanDesignationAuthorisationStatus | 1..1 | CD | This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4) | |
| OrphanDesignationAuthorisationDate | 0..1 | DT | This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5) | |
| OrphanDesignationNumber | 0..1 | II | This field is to indicate the orphan designation decision number. (9.2.2.3.6) | |
| PackagedMedicinalProduct | 1..* | Class | 9.6.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| PCID | 1..1 | II | This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1) | |
| PackageDescription | 1..1 | ST | A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2) | |
| BatchIdentifier | 0..* | Class | 9.6.2.8 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| BAID1 | 1..1 | II | The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1) | |
| BAID2 | 0..1 | II | The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2) | |
| ExpirationDate | 1..1 | DT | This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| MarketingAuthorisation | 0..1 | Class | 9.3.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| MarketingAuthorisationNumber | 1..1 | II | The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2) | |
| Country | 1..* | CD | The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3) | |
| LegalStatusOfSupply | 1..1 | CD | The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4) | |
| AuthorisationStatus | 1..1 | CD | The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5) | |
| AuthorisationStatusDate | 1..1 | DT | The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6) | |
| ValidityPeriodStart | 1..1 | DT | The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7) | |
| ValidityPeriodEnd | 1..1 | DT | The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8) | |
| DataExclusivityStartDate | 0..1 | DT | The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9) | |
| DataExclusivityEndDate | 0..1 | DT | The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10) | |
| DateOfFirstAuthorisation | 0..1 | DT | The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11) | |
| InternationalBirthDate | 1..1 | DT | This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12) | |
| JurisdictionalMarketingAuthorisation | 0..* | Class | 9.3.2.10 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2) | |
| Jurisdiction | 0..1 | CD | This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3) | |
| MarketingAuthorisationNumber | 0..1 | II | The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4) | |
| LegalStatusOfSupply | 0..1 | CD | The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5) | |
| MarketingAuthorisationHolder_Organisation | 1..1 | Class | 9.3.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SME | 0..1 | Class | 9.3.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SMEFlag | 1..1 | BL | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) | |
| Size | 0..1 | CD | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) | |
| SMENumber | 0..1 | II | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) | |
| StatusDate | 0..1 | DT | This is the date when the SME status was granted. (9.3.2.4.4) | |
| MarketingAuthorisationProcedure | 1..1 | Class | 9.3.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ProcedureIdentifier-Number | 0..1 | II | The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2) | |
| ProcedureType | 1..1 | CD | The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3) | |
| ProcedureDateStart | 0..1 | DT | The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4) | |
| ProcedureDateEnd | 0..1 | DT | The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5) | |
| MarketingAuthorisationApplication | 0..* | Class | 9.3.2.7 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ApplicationIdentifier-Number | 1..1 | II | A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2) | |
| ApplicationType | 1..1 | CD | The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3) | |
| ApplicationDate | 1..1 | DT | The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4) | |
| MedicinesRegulatoryAgency_Organisation | 1..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| MarketingStatus | 0..* | Class | 9.3.2.8 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Country | 1..1 | CD | The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2) | |
| Jurisdiction | 0..1 | CD | Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3) | |
| MarketingStatus | 1..1 | CD | This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4) | |
| MarketingDateStart | 1..1 | DT | The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5) | |
| MarketingDateStop | 1..1 | DT | The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6) | |
| RiskOfSupplyShortage | 0..1 | BL | Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7) | |
| RiskOfSupplyShortageComment | 0..1 | ST | Any additional comment on supply shortage. (9.3.2.8.8) | |
| StatusReasons | 0..1 | Class | 9.3.2.9 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Reason | 0..1 | CD | The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2) | |
| ReasonComment | 0..1 | ST | Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3) | |
| LegalGrounds | 0..1 | CD | The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4) | |
| LegalGroundsComment | 0..1 | ST | Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5) | |
| RestoreDate | 0..1 | DT | The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6) | |
| ConditionToRestore | 0..1 | CD | The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7) | |
| ConditionToRestoreComment | 0..1 | ST | Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8) | |
| ChangeRequestOrganisationType | 0..1 | CD | The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9) | |
| GeographicAreaForActionTaken | 0..1 | CD | The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10) | |
| PackageItem_Container | 1..* | Class | 9.6.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| PackageItem_ContainerType | 1..1 | CD | The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2) | |
| PackageItem_ContainerQuantity | 1..1 | PQ | The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3) | |
| Material | 1..* | CD | The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4) | |
| AlternateMaterial | 0..* | CD | The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5) | |
| DataCarrierIdentifier | 0..* | Class | 9.6.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2) | |
| Value | 1..1 | CD | The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3) | |
| Device | 0..* | Class | 9.6.2.12 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| DeviceType | 1..1 | CD | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) | |
| DeviceTradeName | 0..1 | ST | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) | |
| DeviceQuantity | 1..1 | PQ | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) | |
| DeviceListingNumber | 0..1 | ST | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) | |
| DeviceIdentifier | 0..1 | II | A unique device identifier needs to be specified. (9.6.2.12.6) | |
| ModelNumber | 0..1 | ST | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) | |
| SterilityIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) | |
| SterilisationRequirementIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) | |
| DeviceUsage | 0..1 | CD | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) | |
| DeviceBatchIdentifier | 0..* | Class | 9.6.2.15 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| BatchNumber | 1..1 | ST | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) | |
| ExpirationDate | 1..1 | DT | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) | |
| DeviceMaterial | 0..* | Class | 9.6.2.13 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) | |
| Alternate | 0..1 | BL | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) | |
| DeviceNomenclature | 0..* | Class | 9.6.2.14 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) | |
| Value | 1..1 | CD | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| ManufacturedItem | 0..* | Class | 9.6.2.20 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ManufacturedDoseForm | 1..1 | CD | This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2) | |
| UnitOfPresentation | 0..1 | CD | This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3) | |
| ManufacturedItemQuantity | 1..1 | PQ | The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4) | |
| Ingredient | 1..* | Class | 9.7.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IngredientRole | 1..1 | CD | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SpecifiedSubstance | 0..* | Class | 9.7.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SpecifiedSubstance | 1..1 | CD | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) | |
| SpecifiedSubstanceGroup | 1..1 | CD | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) | |
| Strength | 0..* | Class | 9.7.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Substance | 0..1 | Class | 9.7.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) | |
| Strength | 1..* | Class | 9.7.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| Package_Component | 0..* | Class | 9.6.2.9 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ComponentType | 1..1 | CD | The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2) | |
| ComponentMaterial | 0..* | CD | The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3) | |
| ComponentAlternateMaterial | 0..* | CD | Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| PharmaceuticalProduct | 1..* | Class | 9.8.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| AdministrableDoseForm | 1..1 | CD | This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2) | |
| UnitOfPresentation | 0..1 | CD | The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3) | |
| Device | 0..* | Class | 9.6.2.12 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| DeviceType | 1..1 | CD | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) | |
| DeviceTradeName | 0..1 | ST | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) | |
| DeviceQuantity | 1..1 | PQ | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) | |
| DeviceListingNumber | 0..1 | ST | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) | |
| DeviceIdentifier | 0..1 | II | A unique device identifier needs to be specified. (9.6.2.12.6) | |
| ModelNumber | 0..1 | ST | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) | |
| SterilityIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) | |
| SterilisationRequirementIndicator | 0..1 | CD | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) | |
| DeviceUsage | 0..1 | CD | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) | |
| DeviceBatchIdentifier | 0..* | Class | 9.6.2.15 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| BatchNumber | 1..1 | ST | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) | |
| ExpirationDate | 1..1 | DT | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) | |
| DeviceMaterial | 0..* | Class | 9.6.2.13 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) | |
| Alternate | 0..1 | BL | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) | |
| DeviceNomenclature | 0..* | Class | 9.6.2.14 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) | |
| Value | 1..1 | CD | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| OtherCharacteristics | 0..* | Class | 9.6.2.22 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) | |
| Value | 1..1 | CD | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) | |
| PhysicalCharacteristics | 0..1 | Class | 9.6.2.21 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Height | 0..1 | PQ | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) | |
| Width | 0..1 | PQ | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) | |
| Depth | 0..1 | PQ | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) | |
| Weight | 0..1 | PQ | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) | |
| NominalVolume | 0..1 | PQ | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) | |
| ExternalDiameter | 0..1 | PQ | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) | |
| Shape | 0..1 | ST | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) | |
| Colour | 0..* | ST | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) | |
| Imprint | 0..* | ST | Where applicable, the imprint can be specified as text. (9.6.2.21.10) | |
| Image | 0..* | ED | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) | |
| Scoring | 0..1 | CD | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) | |
| ShelfLife-Storage | 0..* | Class | 9.6.2.11 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ShelfLifeType | 1..1 | CD | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) | |
| ShelfLifeTimePeriod | 1..1 | PQ | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) | |
| SpecialPrecautionsForStorage | 0..* | CD | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) | |
| Ingredient | 1..* | Class | 9.7.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IngredientRole | 1..1 | CD | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) | |
| AllergenicIndicator | 0..1 | BL | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) | |
| Manufacturer-Establishment_Organisation | 0..* | Class | 9.5.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| Manufacturing-BusinessOperation | 1..* | Class | 9.5.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| OperationType | 1..1 | CD | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) | |
| ManufacturingAuthorisationReferenceNumber | 0..1 | II | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) | |
| EffectiveDate | 0..1 | DT | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) | |
| ConfidentialityIndicator | 0..1 | CD | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) | |
| MedicinesRegulatoryAgency_Organisation | 0..1 | Class | 9.3.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Identifier | 1..1 | II | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) | |
| Name | 1..1 | ST | The name of the organisation shall be provided in text. (9.4.2.2.3) | |
| Address | 1..1 | AD | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) | |
| Contact | 1..* | Class | 9.4.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Name | 0..1 | PN | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) | |
| Telecom | 1..* | TEL | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) | |
| Role | 1..1 | CD | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) | |
| OtherLocations | 0..* | Class | 9.4.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| LocationName | 0..1 | ST | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) | |
| LocationAddress | 1..1 | AD | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) | |
| LocationRole | 1..1 | CD | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) | |
| Identifier | 0..1 | II | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) | |
| GeographicCoordinates | 0..1 | ST | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) | |
| SpecifiedSubstance | 0..* | Class | 9.7.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| SpecifiedSubstance | 1..1 | CD | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) | |
| SpecifiedSubstanceGroup | 1..1 | CD | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) | |
| ConfidentialityIndicator | 0..1 | CD | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) | |
| Strength | 0..* | Class | 9.7.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| Substance | 0..1 | Class | 9.7.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Substance | 1..1 | CD | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) | |
| Strength | 1..* | Class | 9.7.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Strength_Presentation | 1..1 | RTO | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) | |
| Strength_Concentration | 0..1 | RTO | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) | |
| MeasurementPoint | 0..1 | ST | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) | |
| Country | 0..* | CD | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) | |
| ReferenceStrength | 0..* | Class | 9.7.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ReferenceSubstance | 0..1 | CD | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) | |
| ReferenceSpecifiedSubstance | 0..1 | CD | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) | |
| ReferenceStrength | 1..1 | RTO | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) | |
| ReferenceStrengthMeasurementPoint | 0..1 | ST | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) | |
| ReferenceStrengthCountry | 0..* | CD | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) | |
| PharmaceuticalProductCharacteristics | 0..* | Class | 9.8.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2) | |
| Value | 1..1 | CD | The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3) | |
| Status | 0..1 | CD | The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4) | |
| PhPIDSet | 1..* | Class | 9.8.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| PhPIDIdentifierSets | 1..1 | II | This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0) | |
| RouteOfAdministration | 1..* | Class | 9.8.2.3 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| RouteOfAdministration | 1..1 | CD | The route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0) | |
| ProductClassification | 0..* | Class | 9.2.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| CodeSystem | 1..1 | CD | The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2) | |
| Value | 1..1 | CD | The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3) | |
| ProductCross-Reference | 0..* | Class | 9.2.2.7 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| I_MPIDCross-Reference | 1..1 | II | This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2) | |
| ReferencedProductType | 0..1 | CD | This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3) | |
| TherapeuticIndication | 1..* | Class | 9.9.2.2 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| IndicationText | 1..1 | ST | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) | |
| IndicationAsDisease-Symptom-Procedure | 0..1 | CD | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) | |
| DiseaseStatus | 0..1 | CD | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) | |
| Comorbidity | 0..* | CD | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) | |
| IntendedEffect | 0..1 | CD | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) | |
| Timing-Duration | 0..1 | PQ | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) | |
| OtherTherapySpecifics | 0..* | Class | 9.9.2.6 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| TherapyRelationshipType | 1..1 | CD | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) | |
| Medication | 1..1 | CD | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) | |
| PopulationSpecifics | 1..* | Class | 9.9.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| UndesirableEffects | 0..* | Class | 9.9.2.4 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| UndesirableEffectText | 1..1 | ST | The text of the undesirable effect shall be given. (9.9.2.4.2) | |
| UndesirableEffectAsSymptom-Condition-Effect | 0..1 | CD | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) | |
| Symptom-Condition-EffectClassification | 0..1 | CD | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) | |
| FrequencyOfOccurrence | 0..1 | CD | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) | |
| PopulationSpecifics | 0..* | Class | 9.9.2.5 | |
| @id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Age | 0..1 | CD | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) | |
| AgeRangeLow | 0..1 | PQ | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) | |
| AgeRangeHigh | 0..1 | PQ | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) | |
| Gender | 0..1 | CD | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) | |
| Race | 0..1 | CD | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) | |
| PhysiologicalCondition | 0..1 | CD | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) | |
| Documentation for this format | ||||
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Base
Summary
Mandatory: 0 element (353 nested mandatory elements)
Structures
This structure refers to these other structures:
IG © 2021+ My Organization. Package my-ig#1.0.0 based on FHIR 4.0.1. Generated 2023-10-31
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